510(k) K043398

MODIFICATION TO VASCUPUNCTURE PICC GUIDEWIRE by Neometrics, Inc. — Product Code DQX

K043398 is an FDA 510(k) premarket notification submitted by Neometrics, Inc. for the device "MODIFICATION TO VASCUPUNCTURE PICC GUIDEWIRE". The FDA issued a decision of Substantially Equivalent on March 1, 2005. The device falls under product code DQX (Wire, Guide, Catheter), a Class II device regulated under 21 CFR 870.1330. Neometrics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 2005
Date Received
December 10, 2004
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wire, Guide, Catheter
Device Class
Class II
Regulation Number
870.1330
Review Panel
CV
Submission Type